Re: compliance with 21 cfr part 11
| От | Robin |
|---|---|
| Тема | Re: compliance with 21 cfr part 11 |
| Дата | |
| Msg-id | BLU0-SMTP96C29EC0D31AEB42ABAB45E2D70@phx.gbl обсуждение исходный текст |
| Ответ на | Re: compliance with 21 cfr part 11 (Rob Sargent <robjsargent@gmail.com>) |
| Ответы |
Re: compliance with 21 cfr part 11
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| Список | pgsql-general |
I have built big nationwide health databases, and other secure systems requiring traceback and auditability.
The more you are able to make the required processes transparent to the end user, the happier they are and the fewer problems you have from a user acceptance perspective.
Audit does belong in the database, go and look at where the likes of Sybase ASE and DB2 do it. If you do it up front, you are continually maintaining it.
Few systems control appropriate access to data; that is a harder and proprietary trick.
The more you are able to make the required processes transparent to the end user, the happier they are and the fewer problems you have from a user acceptance perspective.
Audit does belong in the database, go and look at where the likes of Sybase ASE and DB2 do it. If you do it up front, you are continually maintaining it.
Few systems control appropriate access to data; that is a harder and proprietary trick.
Robin St.Clair
On 05/12/2013 00:07, Rob Sargent wrote:On 12/04/2013 04:41 PM, John R Pierce wrote:On 12/4/2013 3:34 PM, e-letter wrote:I've been through 21 cfr part 11 (successfully) and it has nothing to do with the database vendor and everything to do with how you track changes to the data.Can postgresql be deployed with audit trail and data validation
capability, to meet compliance with 21 cfr part 11?
IMHO, that sort of audit trail should be higher level in your business logic, not in the database. but that's just my opinion, worth exactly what you paid for it.
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